Systems and methods for deploying a cardiac anchor

ABSTRACT

A heart implant alignment and delivery device includes an elongate body having an opening that is disposed near a distal end of the elongate body. The opening is configured so that a heart implant is positionable within the opening with the heart implant exposed to a surrounding environment and so that the heart implant is substantially aligned with the distal end of the elongate body. The device also includes an implant reposition member, such as a cable, that is releasably coupleable with the heart implant and that is operationally coupled with the elongate body so that a first operation of the implant reposition member causes the heart implant to be retractably deployed from the opening of the elongate body. The first operation of the implant reposition member may be effected via a handle mechanism that is attached to a proximal end of the elongate body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Patent Application No.62/216,835 filed Sep. 10, 2015, entitled “Systems and Methods forDeploying a Cardiac Anchor,” the entire disclosure of which is herebyincorporated by reference, for all purposes, as if fully set forthherein.

BACKGROUND

Heart implants are currently used to resize or alter the geometry of aventricle in a failing heart, such as by reducing its radius ofcurvature through the process of excluding a portion of thecircumference from contact with blood, and thereby reduce wall stress onthe heart and improve the heart's pumping performance. Congestive heartfailure may, for example, be treated using one or more implants whichare selectively positioned relative to a first wall of the heart(typically an interventricular septum), and another wall of the heart soas to exclude scar tissue and limit a cross sectional area, or distanceacross a ventricle. Functional deterioration of the heart tissues may beinhibited by decreasing a size of the heart chamber and/or approximatingtissues so that stress on the tissues is limited.

Congestive heart failure (sometimes referred to as “CHF” or “heartfailure”) is a condition in which the heart does not pump enough bloodto the body's other organs. Congestive heart failure may in some casesresult from narrowing of the arteries that supply blood to the heartmuscle, high blood pressure, heart valve dysfunction due to degenerativeprocesses or other causes, cardiomyopathy (a primary disease of theheart muscle itself), congenital heart defects, infections of the hearttissues, and the like. However, in many cases congestive heart failuremay be triggered by a heart attack or myocardial infarction. Heartattacks can cause scar tissue that interferes with the heart muscle'shealthy function, and that scar tissue can progressively replace moreand more of the contractile heart tissue. More specifically, thepresence of the scar may lead to a compensatory neuro-hormonal responseby the remaining, non-infarcted myocardium leading to progressivedysfunction and worsening failure.

People with heart failure may have difficulty exerting themselves, oftenbecoming short of breath, tired, and the like. As blood flow out of theheart decreases, pressure within the heart increases. Not only doesoverall body fluid volume increase, but higher intracardiac pressureinhibits blood return to the heart through the vascular system. Theincreased overall volume and higher intracardiac pressures result incongestion in the tissues. Edema or swelling may occur in the legs andankles, as well as other parts of the body. Fluid may also collect inthe lungs, interfering with breathing (especially when lying down).Congestive heart failure may also be associated with a decrease in theability of the kidneys to remove sodium and water, and the fluid buildupmay be sufficient to cause substantial weight gain. With progression ofthe disease, this destructive sequence of events can cause theprogressive deterioration and eventual failure of the remainingfunctional heart muscle.

Treatments for congestive heart failure may involve rest, dietarychanges, and modified daily activities. Various drugs may also be usedto alleviate detrimental effects of congestive heart failure, such as bydilating expanding blood vessels, improving and/or increasing pumping ofthe remaining healthy heart tissue, increasing the elimination of wastefluids, and the like.

Surgical interventions have also been applied for treatment ofcongestive heart failure. If the heart failure is related to an abnormalheart valve, the valve may be surgically replaced or repaired.Techniques also exist for exclusion of the scar and volume reduction ofthe ventricle. These techniques may involve (for example) surgical leftventricular reconstruction, ventricular restoration, the Dor procedure,and the like. If the heart becomes sufficiently damaged, even moredrastic surgery may be considered. For example, a heart transplant maybe the most viable option for some patients. These surgical therapiescan be at least partially effective, but typically involve substantialpatient risk. While people with mild or moderate congestive heartfailure may benefit from these known techniques to alleviate thesymptoms and/or slow the progression of the disease, less traumatic, andtherefore, less risky therapies which significantly improve the heartfunction and extend life of congestive heart failure patients hasremained a goal.

It has been proposed that an insert or implant be used to reduceventricular volume of patients with congestive heart failure. Withcongestive heart failure, the left ventricle often dilates or increasesin size. This can result in a significant increase in wall tension andstress. With disease progression, the volume within the left ventriclegradually increases and blood flow gradually decreases, with scar tissueoften taking up a greater and greater portion of the ventricle wall. Byimplanting a device which brings opposed walls of the ventricle intocontact with one another, a portion of the ventricle may be excluded orclosed off. By reducing the overall size of the ventricle, particularlyby reducing the portion of the functioning ventricle chamber defined byscar tissue, the heart function may be significantly increased and theeffects of disease progression at least temporarily reversed, halted,and/or slowed.

BRIEF DESCRIPTION

The embodiments described herein are particularly useful for positioninganchors or heart implants against heart walls. According to one aspect,a catheter for delivering and aligning a heart implant about a wall of aheart is provided. The catheter includes an elongate catheter bodyhaving a lumen disposed there through and a handle mechanism that isdisposed at a proximal end of the elongate catheter body. The elongatecatheter body includes a cavity that is positioned near a distal end ofthe elongate catheter body. The cavity is configured to deliver a heartimplant adjacent the wall and is configured to receive the heart implantin a manner such that at least a portion of the heart implant is exposedto an interior region of the heart. A cable is positioned within thelumen of the elongate catheter body. The cable is releasably coupledwith the heart implant that is positioned within the cavity and isoperationally coupled with the handle mechanism so that a firstoperation of the handle mechanism causes the cable to flex outward fromthe cavity, which causes at least part of the heart implant to moveoutward from the cavity.

The catheter may be further configured so that a second operation of thehandle mechanism causes the cable to retract within the lumen of theelongate catheter body, thereby enabling the heart implant to berepositioned within the cavity. The catheter may be even furtherconfigured so that a third operation of the handle mechanism causes thecable to retract within the lumen of the elongate catheter body therebyenabling the heart implant to be released from the cavity. The heartimplant may be pivotably coupled with a tension member.

A distal tip of the elongate catheter body may be plugged, capped,solid, or otherwise closed so that the lumen does not extend through thedistal tip. A distal end of the cable may contact the distal tip of theelongate catheter body so that distal sliding of the cable within thelumen causes the cable to flex outward from the cavity. The cavity maybe formed in the distal end of the elongate catheter body by removingmore with more than ½ of the material of the elongate catheter body. Astrip of material may connect a proximal portion and a distal portion ofthe elongate catheter body on opposite sides of the cavity. The cablemay be slidably disposed through a lumen of the heart implant in orderto couple the heart implant with the cavity and elongate catheter body.The distal end of the elongate catheter body may flex or bend inresponse to the first operation of the handle mechanism and the heartimplant may pivot outward from the cavity in response to the firstoperation of the handle mechanism.

According to another aspect, a heart implant alignment and deliverydevice is provided. The device includes an elongate body and an openingin the elongate body that is disposed near a distal end of the elongatebody. The opening is configured so that a heart implant is positionablewithin the opening with the heart implant exposed to a surroundingenvironment, and so that the heart implant is substantially aligned withthe distal end of the elongate body. The device also includes an implantreposition member that is releasably coupleable with the heart implantand that is operationally coupled with the elongate body so that a firstoperation of the implant reposition member causes the heart implant tobe retractably deployed from the opening of the elongate body.Retractably deploying the heart implant may involve pivoting the heartimplant out of the opening of the elongate body.

The implant reposition member may be also configured so that a secondoperation of the implant reposition member causes the heart implant tobe retracted into the opening with the heart implant substantiallyaligned or realigned with the distal end of the elongate body. Theimplant reposition member may be further configured so that a thirdoperation of the implant reposition member causes the heart implant tobe permanently deployed from the opening of the elongate body. Thedevice may include a handle mechanism that is disposed at a proximal endof the elongate body. The handle mechanism may be operably coupled withthe implant reposition member to effect the first operation, the secondoperation, and/or the third operation of the implant reposition member.The implant reposition member may be a cable that is slidably disposedwithin a lumen of the elongate body and the elongate body may beconfigured so that the distal sliding of the cable within the lumen ofthe elongate body causes a portion of the cable to protrude outwardlyfrom the opening.

According to another aspect, a method of deploying a heart implant froma catheter is provided. The catheter includes an elongate body having alumen and a cavity, a cable disposed within the lumen, and a handlemechanism disposed at a proximal end of the elongate body. The heartimplant is positioned within the cavity of the elongate body. The methodincludes positioning a distal end of the elongate body within a chamberof a heart so that the cavity and heart implant are adjacent a wall ofthe heart and performing a first operation via the handle mechanism tocause the cable to flex outward from the cavity of the elongate body andthereby cause the heart implant to pivot out of the cavity of theelongate body and into contact with the wall. The catheter is configuredso that the heart implant is retractable within the cavity to enablerepositioning of the elongate body within the heart and thereby ensure aproper alignment of the heart implant relative to the wall of the heart.

The method may also include performing a second operation via the handlemechanism to cause the cable to retract within the lumen of the elongatebody and thereby cause the heart implant to retract into the cavity. Thecavity and heart implant may then be repositioned within the cavity ofthe heart after retraction of the cable and heart implant. The methodmay additionally include repositioning the cavity and heart implantwithin the chamber of the heart so that the heart implant isrepositioned relative to the wall. The first operation of the handlemechanism may then be performed again to cause the cable to flex outwardfrom the cavity and thereby cause the heart implant to pivot out of thecavity and into contact with the wall. The method may additionallyinclude performing a third operation with the handle mechanism topermanently deploy the heart implant from the cavity of the elongatebody. The heart implant may be pivotably coupled with a tension memberthat extend distally from heart implant and through the wall of theheart. The cable may be slidably disposed through a lumen of the heartimplant.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is described in conjunction with the appendedfigures:

FIGS. 1A-C illustrate various views of a heart implant alignment anddelivery device that may be used to deliver, align, and deploy a heartimplant within a heart.

FIGS. 2A-C illustrate cross sectional views of a handle mechanism of theheart implant alignment and delivery device of FIGS. 1A-C.

FIGS. 3A-C illustrate cross sectional views of a distal end of the heartimplant alignment and delivery device of FIGS. 1A-C.

FIGS. 4A-B illustrate a deployment of a heart implant from a cavity ofthe distal end of the heart implant alignment and delivery device.

FIGS. 5A-C illustrate a method of deploying a heart implant from theheart implant alignment and delivery device and within a chamber of aheart.

FIG. 6 illustrates an image of a heart implant being positioned within aright ventricle of an animal.

In the appended figures, similar components and/or features may have thesame numerical reference label. Further, various components of the sametype may be distinguished by following the reference label by a letterthat distinguishes among the similar components and/or features. If onlythe first numerical reference label is used in the specification, thedescription is applicable to any one of the similar components and/orfeatures having the same first numerical reference label irrespective ofthe letter suffix.

DETAILED DESCRIPTION

The ensuing description provides exemplary embodiments only, and is notintended to limit the scope, applicability or configuration of thedisclosure. Rather, the ensuing description of the exemplary embodimentswill provide those skilled in the art with an enabling description forimplementing one or more exemplary embodiments. It being understood thatvarious changes may be made in the function and arrangement of elementswithout departing from the spirit and scope of the invention as setforth in the appended claims.

The embodiments herein generally provide improved medical devices,systems, and methods. Exemplary embodiments of the devices are describedfor use in reducing the distance between a region along the septum and aregion of an external wall of the left and/or right ventricle of a heartin a less or minimally invasive manner. Hence, embodiments of the toolsand methods described herein may find specific use in the treatment ofcongestive heart failure and other progressive heart diseases byreconfiguring abnormal heart geometry that may be contributing to heartdysfunction.

The embodiments of the tools and methods described herein areparticularly useful for positioning anchors or heart implants that aredeployed against the heart walls and that are used to urge opposingheart walls together. The tools and methods allow a physician to haveimproved control over the position and deployment of the anchor againstthe heart wall. The improved control enables the physician to ensurethat Chordae, Papillary Leaflets, the Tricuspid Valve, and other hearttissue or material are not contacted, entangled, or otherwisedetrimentally affected by the heart anchor. The tools and methods alsoallow the physician to easily reposition the heart anchor if suchrepositioning is needed. The embodiments herein enable more precisepositioning of heart anchors within a chamber of the heart, which maygreatly simplify the heart anchor delivery procedure and/or reduceoperation and recovery time associated with the procedure.

The controlled placement of the heart anchor is achieved via a catheteror heart implant alignment and delivery device that is configured todeliver the heart anchor within the chamber in a manner that enables theheart anchor to be retractably pivoted or deployed from the catheter.Stated differently, the catheter is designed so that the heart anchormay be deployed from the catheter, but the deployment is controlled sothat the heart anchor is not permanently or non-reversibly deployed fromthe catheter. Rather, the heart anchor remains coupled with the cathetereven after an initial deployment, which enables the heart anchor to beretracted against or relative to the catheter if desired.

The retractable deployment of the heart anchor allows a physician tocheck or inspect a placement, position, or other deployment relatedcharacteristic of the heart anchor prior to permanently deploying theheart anchor. For example, the physician may inspect that the heartanchor is properly aligned about the heart, and/or in relation toanother heart anchor, to ensure that a desired closure or othertreatment of the heart will be achieved via the heart anchor. In otherinstances, the physician may ensure that the heart anchor is notentangled with or in contact with sensitive heart tissue, such as theChordae, Papillary Leaflets, Tricuspid Valve, etc. If the physiciandetermines that the heart anchor is not properly aligned about theheart, and/or with another heart anchor, the physician may retract theheart anchor, reposition the heart anchor, and retractably deploy theheart anchor to ensure that a desired and proper alignment and/orplacement of the heart anchor is achieved.

After a desired placement or alignment of the heart anchor is achieved,the physician may then permanently deploy the heart anchor from thecatheter. The heart anchor may then be used to partially or fully closea portion of the heart as desired. In some instances, retractabledeployment of the heart anchor may involve positioning of the heartanchor against one of the walls of the heart, such as adjacent theseptum. In other embodiments, the heart anchor may be deployed elsewhererelative to the heart. The physician may inspect the placement orposition of the heart anchor via fluoroscopy, echocardiography (e.g., 3Dechocardiography, Transesophageal Echocardiography (TEE)), and the like.

The catheter may include an elongate body that includes an opening bodythat is disposed near a distal end of the elongate body. The elongatebody is typically a cylindrical body or tubing. The opening isconfigured so that a heart implant may be positioned within the opening.The opening is typically formed in a portion of the elongate body byremoving some of the tubing's material, which may expose an interiorportion of the tubing or elongate body. With the material removed, asmall strip or section of the elongate body or tubing may connect adistal and proximal portion of the elongate body.

The heart anchor may be positioned within the opening so that one sideof the heart anchor faces the interior of the elongate body. The heartimplant is typically exposed to a surrounding environment whenpositioned within the opening. The heart implant is also typicallyaligned with the distal end of the elongate body or tubing. The catheteralso includes an implant reposition member that is releasably coupledwith the heart implant when the heart implant is positioned within theopening. In one embodiment, the implant reposition member is a cable,wire, or cord that is positioned through a lumen of the elongate bodyand through a lumen of the heart implant. In other embodiments, theimplant reposition member may be any component or member that is able toattach to the heart implant in a manner that allows the heart implant tobe retractably deployed from the catheter.

The implant reposition member is operationally coupled with the elongatebody so that a first operation of the implant reposition member causesthe heart implant to be retractably deployed from the opening of theelongate body. The implant reposition member may be attached to a handlemechanism that is disposed at a proximal end of the elongate body andthat is operable to effect the first operation of the implant repositionmember. Retractable deployment of the heart implant may includingpivoting of the heart implant out of the opening of the elongate body.

The implant reposition member is also configured so that a secondoperation of the implant reposition member causes the heart implant tobe retracted into the opening of the elongate body. Upon retraction ofthe heart implant within the opening, the heart implant is once againsubstantially aligned with the distal end of the elongate body. Thehandle mechanism may be designed to effect the second operation of theimplant reposition member. The implant reposition member is furtherconfigured so that a third operation of the implant reposition membercauses the heart implant to be permanently deployed from the opening ofthe elongate body. The handle mechanism may be designed to effect thethird operation of the implant reposition member. In instances where theimplant reposition member is a cable, the cable may be slidably disposedwithin a lumen of the elongate body and the elongate body may beconfigured so that distal sliding of the cable within the lumen of theelongate body causes a portion of the cable to protrude outwardly fromthe opening.

Having generally described aspects of a heart implant deliver device orcatheter, additional features of such devices will be more apparent inreference to the description of the various figures that is providedbelow.

Referring now to the FIGS. 1A-1C, illustrated are various view of aheart implant alignment and delivery device or catheter (hereinaftercatheter 100) that may be used to deliver, align, and deploy a heartimplant or anchor 120 (hereinafter heart implant 120) within the heart.The catheter 100 has a proximal end 102 and a distal end 104. A handlemechanism 106 (hereinafter handle 106) is attached to the proximal end102 of the catheter 100. The handle 106 may be used by a physician tocontrol and navigate the distal end 104 of the catheter 100 within thevasculature of a patient's body. Specifically, the distal end 104 may bedirected or navigated to a desired location within or adjacent a chamberof the heart for deployment of one or more heart implants 120. Thehandle 106 is also used in aligning and/or deploying the heart implant120 within the heart as described in greater detail herein.

The distal end 104 includes an elongate or catheter body 108(hereinafter elongate body 108) having a lumen 110 (see FIG. 3A) thatextends substantially through the elongate body 108. The elongate body108 is typically a cylindrical body or section of flexible tubing. Insome embodiments, the elongate body 108 may be made of a braid material,catheter, or tubing, such as braid reinforced tubing. The elongate body108 is sufficiently flexible to allow the tubing to be inserted throughthe vasculature of the patient and within a chamber of the heart. Thetubing should be sufficiently flexible and strong to enable insertionwithin the vasculature while minimizing trauma to the patient. A cable,wire, flexible rod, or other component 112 (hereinafter cable 112) isslidably positioned within the lumen 110 of the elongate body 108. Asillustrated in greater detail in FIGS. 2A-C, the cable 112 isoperationally coupled with the handle 106 so that an operation of thehandle 106 causes the cable 112 to slide proximally and distally withinthe lumen 110 of the elongate body 108, which effects deployment orretraction of the heart implant 120. Specifically, as described ingreater detail below, a grip member 202 of the handle 106 may be slidproximally and distally about the handle 106 to initially deploy andretract the heart implant 120. A release member 208 may be employed topermanently deploy the heart implant 120 after a proper alignment orpositioning of the implant is determined.

An opening or cavity 114 (hereinafter cavity 114) is formed in thedistal end 104 of the elongate body 108. The cavity 114 is configured sothat the heart implant 120 may be positioned within the cavity 114. Thecavity 114 is formed in the distal end 104 of the elongate body 108 byremoving some of the tubing's material (typically more than ½ of thematerial), which exposes an interior portion of the tubing and lumen110. In some embodiments, the cavity 114 may be formed via laser cuttingor machining. Laser cutting may be particularly useful when the elongatebody 108 is formed of a braid material, since the laser may prevent orminimize fraying of the braid material As illustrated in FIG. 1C, asmall strip or material section 115 of the elongate body 108 connects adistal and proximal portion of the elongate body 108 adjacent the cavity114. The heart implant 120 is positionable within the cavity 114 of theelongate body 108. When positioned within the cavity 114, an exteriorsurface of the heart implant 120 is positioned against the elongate body108, although the heart implant 120 generally remains exposed to asurrounding environment as illustrated. The heart implant 120 is alsosubstantially aligned within the distal end 104 of the elongate body 108when positioned within the cavity 114.

The heart implant 120 is pivotally coupled or attached to a tether ortension member 122 (hereinafter tether 122). Exemplary heart implants120 and tethers 122 are further described in the following U.S.applications, the disclosures of which are incorporated by referenceherein: U.S. application Ser. No. 13/632,108, filed Sep. 30, 2012,entitled “Over-the-Wire Cardiac Implant Delivery System for Treatment ofCHF and Other Condition”; U.S. application Ser. No. 13/632,106, filedSep. 30, 2012, entitled “Cardiac Implant Migration Inhibiting Systems”;U.S. application Ser. No. 13/632,104, filed Sep. 30, 2012, entitled“Trans-Catheter Ventricular Reconstruction Structures, Methods, andSystems for Treatment of Congestive Heart Failure and Other Conditions”;U.S. application Ser. No. 13/632,103, filed Sep. 30, 2012, entitled“Remote Pericardial Hemostasis for Ventricular Access and Reconstructionor Other Organ Therapies”. As described in said applications, the tether122 may be used to apply tension to the heart walls and/or fix the heartwalls in engaged state to close off a portion of a heart chamber. Thetether 122 may also be used to guide the heart implant 120 to a desiredlocation within the heart chamber. In such instances, the tether 122 mayextend distally of the distal end 104 of the elongate body 108 asillustrated.

The heart implant 120 is coupleable with the elongate body 108 so thatthe heart anchor 120 may be removed or uncoupled therefrom. For example,FIGS. 1A and 1B illustrate the heart implant 120 positioned within thecavity 114 of the elongate body 108 while FIG. 1C illustrated the heartimplant 120 removed therefrom. The heart implant 120 is removablycoupled with the cavity 114 by inserting the cable 112 through a lumen124 of the heart implant 120 as illustrated in greater detail in FIGS.3A and 3B.

The distal tip of the elongate body 108 is plugged, capped, or otherwiseclosed so that the cable 112 is not able to extend entirely through theelongate body 108 and beyond the distal tip of the elongate body 108. Toplug, cap, or close the distal tip, a cap or plug 130 (hereinafter plug130) is coupled or attached to the distal tip. Because the distal tip isplugged, capped, or otherwise closed, distal sliding of the cable 112causes the cable 112 to flex and deploy outward from the cavity 114,which is used in initially deploying the heart implant 120 within theheart chamber.

FIGS. 2A-C illustrate cross sectional views of the handle 106 of thecatheter 100 in greater detail. The handle 106 is configured to begrasped and manipulated by a physician to align and deploy the heartimplant 120 within the heart. FIG. 2A illustrates a cross section of theentire handle 106, while FIGS. 2B and 2C illustrate distal and proximalends of the handle 106, respectively. As illustrated, the cable 112 ispositioned through the lumen 110 of the elongate body 108 and throughthe interior of the handle 106. The cable 112 is fixedly attached to aplunger 206 that is axially movable or slidable within a main body 200of the handle 106. The plunger 206 is attached to the grip member orlever 202 (hereinafter grip member 202) so that axial sliding of thegrip member 202 causes the plunger 206 to move axially within the mainbody 200. In turn, axial movement of the plunger 206 causes the cable112 to similarly move or slide axially within the elongate body 108. Thegrip member 202 may be mechanically attached to the plunger 206 via setscrews 210 or other mechanical fasteners as illustrated. In otherembodiments, the grip member 202 may be adhesively bonded,ultrasonically welded, RF welded, and the like to the plunger 206.

The grip member 202 is slidably disposed within a elongate slot oropening 212 of the main body 200. The elongate slot 212 limits theamount of sliding of the grip member 202 relative to the main body 200,which correspondingly limits the amount of axial sliding of the plunger206 within the main body 200 and thereby limits the amount of axialsliding of the cable 112 within the lumen 110 of the elongate body 108.The catheter 100 may be arranged so that the distal end of the cable 112is adjacent to, or contacts, the plug 130 when the grip member 202 ispositioned at a proximal most point within the elongate slot 212. Insuch instances, distal sliding of the grip member 202 within theelongate slot 212 causes the cable 112 to flex or deploy outwardly fromthe cavity 114 since the plug 130 prevents the cable's distal tip fromextending or protruding beyond the distal tip of the elongate body 108.In this manner, distal sliding of the grip member 202 may be employed toinitially deploy the heart implant 120 from the cavity 114 of theelongate body 108. The grip member 202 may be slid proximally to retractthe cable 112 within the cavity 114 of the elongate body 108. In thismanner, proximal sliding of the grip member 202 may be employed toretract the heart implant 120 within the cavity of the elongate body108.

An access member 204 is coupled with the distal end of the main body200. The access member 204 may couple with the elongate body 108 andreinforce the elongate body 108. The access member 204 may include aport 111 that provides fluid access to the elongate body 108 and/orvasculature. An O-ring 220, or other fluid inhibitor, may be disposedwithin a distal end of the main body 200 at a proximal end of theelongate body 108. The O-ring 220 may be used to fluidly seal theelongate body 108 in order to prevent blood or other bodily fluid frompassing through the elongate body 108 and into the main body 200 of thehandle 106. In some instances, the cable 112 may be reinforced withinthe interior of the main body 200, such as by including a rigid coveringor tubing that prevents or minimizes buckling of the cable 112.

A release member or cable deployment mechanism 208 (hereinafter cabledeployment mechanism 208) is removably attached to the proximal end ofthe plunger 206. The cable deployment mechanism 208 is also fixedlyattached to the cable 112. The cable deployment mechanism 208 isdesigned to be removed or detached from the plunger 206 and pulledproximally relative thereto. Detachment of the cable deploymentmechanism 208 from the plunger 206, and proximal movement of the cabledeployment mechanism 208 relative thereto, causes the cable 112 to beslid proximally within the lumen 110 of the elongate body 108 and out ofengagement with the heart implant 120. This allows the heart implant 120to be permanently deployed or detached from the cavity 114 of theelongate body. The cable deployment mechanism 208 may include a luertype connector, or any other connector, to enable the cable deploymentmechanism 208 to be detached from the proximal end of the plunger 206.

In operation, the handle 106 is used to both initially deploy the heartimplant 120 and to permanently deploy the heart implant 120 once adesired alignment or orientation of the heart implant is achieved. Forexample, the heart implant 120 may be inserted within the patient'svasculature and into a chamber of the heart (e.g., left ventricle). Theheart implant 120 is typically positioned within the cavity 114 of theelongate body 108 during insertion of the heart implant 120 through thevasculature. Insertion of the heart implant 120 within the vasculatureand heart chamber is further described in the various U.S. applicationsincorporated by reference herein.

The grip member 202 may then be slid distally within the elongate slot212 to flex the cable 112 outward from the cavity 114, whichcorrespondingly causes the heart implant 120 to pivot or deploy outwardfrom the cavity 114 due to the coupling of the cable 112 and the heartimplant 120. A physician may determine if the heart implant 120 isproperly aligned or oriented within the heart chamber, or if the heartimplant is in contact with any sensitive tissue. If the heart implant120 is not properly aligned, or if the heart implant 120 contactssensitive tissue, the grip member 202 may be slid proximally within theelongate slot 212 to retract the heart implant 120 within the cavity ofthe elongate body 108. The heart implant may then be realigned orrepositioned within the heart chamber via proximal or distal movement ofthe elongate body 108, rotation of the handle 106 and elongate body 108,etc., and the heart implant 120 may then be redeployed within the heartchamber via the grip member 202 to determine if the new alignment ororientation of the heart implant 120 is proper.

Upon a determination of a proper alignment or orientation of the heartimplant 120, the cable deployment mechanism 208 may be detached from theplunger to disengage the cable 112 from the heart implant 120, whichenables the heart implant 120 to be permanently deployed or detachedfrom the elongate body 108. The heart implant 120 may then be used toapply tension to the heart walls so as to bring opposing heart wallsinto engagement. The heart implant 120 and tether may then be used topermanently affix the engaged heart walls. Tensioning and affixing ofthe heart walls is further described in the various U.S. applicationsincorporated by reference herein.

Referring now to FIGS. 3A-C, illustrated are cross sectional views ofthe distal end 102 of the elongate body 108. FIGS. 3A-C provide greaterdetail of the functional relationship or operation of the cavity 114,heart implant 120, and plug 130. FIG. 3A shows the heart implant 120removed from the cavity 114 and detached from the elongate body 108. Thecable 112 is retracted within the lumen 110 of the elongate body 108 soas to be positioned proximally of a proximal end of the cavity 114. Thecable 112 is typically moved to this position via detachment of thecable deployment mechanism 208 from the plunger 206. FIG. 3B illustratesthe heart implant 120 positioned within the cavity 114 with the heartimplant's lumen 124 substantially axially aligned within an axis of thecavity 114 and the elongate body 108. The cable 112 is inserted throughthe lumen 124 of the heart implant 120, which temporarily couples theheart implant 120 with the elongate body 108. The distal tip of theelongate body 108 is capped, plugged, or otherwise closed via the plug130 to prevent the cable 112 from extending distally beyond the elongatebody 108. The distal tip of the cable 112 is directly adjacent, or incontact with, the plug 130 as illustrated.

Since the cable 112 is positioned internally within the elongate body108, both proximally and distally of the heart implant 120 and cavity114, the heart implant 120 is essentially locked or restrained withinthe cavity 114, which prevents accidental or undesired uncoupling ordetachment of these components. An inner surface of the heart implant120 is in direct contact with the interior of the elongate body 108while the heart implant 120 remains exposed to the surroundingenvironment, which in use is typically the interior of the heartchamber.

The cavity 114 is sized slightly larger than the heart implant 120. Forexample, the cavity 114 has a longitudinal dimension X which is slightlygreater than the longitudinal length Y of the heart implant 120. Thecavity 114 should be dimensioned so that the heart implant may be easilyaligned and coupled with the cavity 114 and so that the cable 112 isable to flex or deploy outward from the cavity 114 in response to distalsliding of the cable 112 within the lumen 110 of the elongate body 108.Stated differently, the cavity 114 should not be dimensioned so that itprevents or greatly restricts the cable 112 from flexing or deployingoutward from the cavity 114, which may occur if the cavity 114 issimilar in size to the longitudinal length of the heart implant 120.

The tether 122 is shown extending distally from the heart implant 120and elongate body 108. The tether 122 may be inserted within thevasculature and heart chamber distally of the heart implant 120 andelongate body 108 and may be used to guide or direct the heart implant120 and elongate body 108 through the vasculature and within the heartchamber. The tether 122 is pivotally attached or coupled with the heartimplant 120 so that the implant is able to pivot about the end of thetether 122.

FIG. 3C illustrates the cable 112 being used to initially deploy orpivot the heart implant 120 from the cavity 114 of the elongate body108. The cable 112 is designed to flex, buckle, or bend in response toan operation of the handle 106 and specifically, the distal movement ofthe grip member 202 within the elongate slot 212 of the main body 200.Distal movement of the grip member 202 causes the plunger 206 to slidedistally within the main body 200, which causes a corresponding distalsliding of the cable 112 within the lumen 110 of the elongate body 108.The plug 130 prevents the cable from extending or sliding distally ofthe distal tip of the elongate body 108, which causes the cable 112 tobuckle and bend or flex outward from the cavity 114 as illustrated.Because the cable 112 is disposed within the lumen 124 of the heartimplant 120, outward flexing or bending of the cable 112 causes theheart implant to pivot, move, or deploy outward from the cavity 114. Thebuckling of the cable 112 may also cause the distal end of the elongatebody 108 to flex or bend in an opposite direction as illustrated in FIG.3C. This flexing or bending of the elongate body 108 may be controlledby increasing or decreasing the thickness of the elongate body'smaterial strip that extends across the cavity 114.

Proximal movement of the grip member 202 causes the plunger 206 to slideproximally within the main body 200, which causes a correspondingproximal sliding of the cable 112 within the lumen 110 of the elongatebody 108. This retracts the cable 112 within the lumen 110 of theelongate body, which causes the heart implant 120 to pivot or move backinto the cavity 114. When the heart implant 120 is retracted within thecavity 114, the lumen 124 is typically realigned with the axis of thecavity 114 and elongate body 108. In this manner, the heart implant 120may be initially deployed from and retracted within the cavity 114. Theheart implant 120 may also be permanently deployed form the cavity 114by detaching the cable deployment mechanism 208 from the plunger 206.

While FIGS. 3A-C illustrate the elongate body 108 including the plug130, in other embodiments the elongate body 108 may be configured sothat the lumen 110 terminates or stops short of the distal end of theelongate body 108 and therefore, does not extend fully through thedistal end of the elongate body 108. In yet other embodiments, thedistal tip of the elongate body 108 may be pinched or formed together toplug, cap, or otherwise close the lumen 110 and thereby prevent thecable 112 from extending distally of the elongate body's distal tip.

FIGS. 4A-B illustrate the deployment of the heart implant 120 from thecavity 114 of the elongate body 108. As described herein, the heartimplant 120 is deployed via operation of the cable 112. Prior todeployment of the heart implant 120, the heart implant 120 may bealigned with the cable 112 and elongate body 108 as illustrated in FIG.4A. The heart implant 120 may be deployed from the cavity 114 in apivot-like manner or fashion. Since the tether 122 is connected to theheart implant 120 via a pivot joint 121, the sliding of the cable 112causes the heart implant 120 to pivot or flex about the pivot joint 121.The bowing or flexing of the cable 112 may also cause the distal portionor end of the elongate body 108 to bow or flex in an opposite directionas shown. The heart implant 120 may be deployed or pivoted relative tothe elongate body 108 so that the heart implant 120 is roughlyorthogonal to an axis of proximal portion of the elongate body 108 asillustrated.

FIGS. 5A-C illustrates a method of deploying the heart implant 120 fromthe catheter 100 and within a chamber 302 (e.g., left ventricle) of aheart 300. In FIG. 5A, the distal end of the elongate body 108 ispositioned within the chamber 302 of the heart 100 so that the cavity114 and heart implant 120 are positioned near or adjacent a septum 304of the heart 300. The tether 122 extends from the heart implant 120 andthrough the septum 304 and an exterior wall 306 of the heart. The tether122 may extend distally therefrom and through an incision within thepatient's body, such as through an incision between the patient's ribs.

In FIG. 3B, a first operation of the handle 106 is performed to causethe cable 112 to flex, buckle, or bend outward from the cavity 114 ofthe elongate body 108 and thereby cause the heart implant 120 to pivotout of the cavity 114. In some instances, the heart implant 120 maypivot into contact with the septum 304. As described herein, the firstoperation of the handle 106 may be a distal sliding of the grip member202 within the elongate slot 212 of the handle's main body 200. Theheart implant 120 is retractable within the cavity 114 to enablerepositioning of the elongate body 108 within the heart 300 and therebyensure a proper alignment of the heart implant 120 relative to the wall304 of the heart 300. For example, with the heart implant 120 pivoted ordeployed from the cavity 114, a physician may assess if the heartimplant 120 is properly aligned or oriented about the septum 304 toprovide a desired therapeutic treatment, such as closing off a desiredportion of the right ventricle.

If the heart implant 120 is not properly aligned or oriented about theseptum 304, then the heart implant 120 may be retracted within thecavity 114. Specifically, a second operation of the handle 106 may beperformed to cause the cable 112 to retract within the lumen 110 of theelongate body 108 and thereby cause the heart implant 120 to retractinto the cavity 114. The heart implant 120 is then repositionable withinthe chamber 302 of the heart 300 after retraction of the cable 112 andheart implant 120. As described herein, the second operation of thehandle 106 may be a proximal sliding of the grip member 202 within theelongate slot 212 of the handle's main body 200.

The elongate body 108 and heart implant 120 may be repositioned withinthe chamber 302 of the heart 300 so that the heart implant 120 isrepositioned relative to the septum 304. The first operation of thehandle 106 (i.e., distal sliding of the grip member 202) may then beperformed again to cause the cable 112 and heart implant 120 to flex orpivot outward from the cavity 114 so that the physician can assess thenew position of the heart implant 120 relative to the septum 304.

As illustrated in FIG. 5C, upon a determination that the alignment ororientation of the heart implant 120 is proper relative to the septum304, a third operation of the handle 106 may be performed to permanentlydeploy the heart implant 120 from the cavity 114 of the elongate body108. As described herein, the third operation of the handle 106 mayinvolve detaching the cable deployment mechanism 208 from the plunger206 of the handle 106 and/or pulling the cable deployment mechanism 208proximally of the plunger 206. Once the heart implant 120 is detachedfrom the cavity 114 and elongate body 108, the elongate body 108 may beremoved from the chamber 302 of the heart 300 and from the patient'sbody. As further described in the various U.S. applications incorporatedherein, the heart implant 120 and tether 122 may then be used to applytension to the septum 304 and exterior wall 306 for various reasonsincluding bringing the inner surfaces of the walls, 304 and 306, intoengagement. The heart implant 120 and tether 122 may also be used topermanently affix the septum 304 and exterior wall 306 in a desiredorientation, such as by affixing an epicardial anchor (not shown) to thetether 122.

Deployment of the heart implant 120 via the cable 112 allows thephysician to have improved control over positioning of the heart implant120 against the heart wall. For example, if the heart implant 120 needsto be rotated relative to the heart wall, the cable 112 may be retractedproximally to cause the heart implant 120 to be repositioned within thecavity 114 and the catheter 100 and elongate body 108 may be rotated tocause the heart implant 120 to be moved rotationally relative to theheart wall. The heart implant 120 may then be redeployed into contactwith the heart wall via the process described herein. Similarly, if theheart implant 120 is contacting, entangling, or otherwise engaging withinternal heart structures during deployment, the cable 112 may beretracted proximally to reposition the heart implant 120 within thecavity 114. The heart implant 120 and/or elongate body 108 may then berotated to reposition the heart implant 120 relative to the heart to aposition where it is less likely that the heart implant 120 willcontact, entangle, or engage with heart structures during deployment.The heart implant 120 may then be redeployed against the heart wallusing the cable 112 and handle 106.

The use of the cable 112 further prevents or minimizes unnecessary andpotentially problematic movement of the heart implant 120 at the distalend of the tether 122. For example, if the heart implant 120 is able tofreely pivot or move at or about the distal end of the tether 122, theheart implant 120 may be prone to contacting and engaging with the hearttissue (e.g., Chordae, Papillary Leaflets, Tricuspid Valve, etc.). Theuse of the cable 112 prevents or minimizes free pivoting or movement ofthe heart implant 120 about the distal end of the tether 122.

FIG. 6 illustrates an image of a heart implant or anchor beingpositioned within a right ventricle of an animal. The left hand imageshows the heart implant or anchor in an un-deployed or insertionposition where an axis of the heart implant or anchor is aligned withthe axis of the elongate body. The right hand image shows the heartimplant or anchor being deployed or pivoted from the elongate body'scavity or anchor window and into contact with the inner surface of theright ventricle via the cable. The heart implant or anchor rests againstthe septum of the heart subsequent to deployment of the anchor.

While several embodiments and arrangements of various components aredescribed herein, it should be understood that the various componentsand/or combination of components described in the various embodimentsmay be modified, rearranged, changed, adjusted, and the like. Forexample, the arrangement of components in any of the describedembodiments may be adjusted or rearranged and/or the various describedcomponents may be employed in any of the embodiments in which they arenot currently described or employed. As such, it should be realized thatthe various embodiments are not limited to the specific arrangementand/or component structures described herein.

In addition, it is to be understood that any workable combination of thefeatures and elements disclosed herein is also considered to bedisclosed. Additionally, any time a feature is not discussed with regardin an embodiment in this disclosure, a person of skill in the art ishereby put on notice that some embodiments of the invention mayimplicitly and specifically exclude such features, thereby providingsupport for negative claim limitations.

Having described several embodiments, it will be recognized by those ofskill in the art that various modifications, alternative constructions,and equivalents may be used without departing from the spirit of theinvention. Additionally, a number of well-known processes and elementshave not been described in order to avoid unnecessarily obscuring thepresent invention. Accordingly, the above description should not betaken as limiting the scope of the invention.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassed.The upper and lower limits of these smaller ranges may independently beincluded or excluded in the range, and each range where either, neitheror both limits are included in the smaller ranges is also encompassedwithin the invention, subject to any specifically excluded limit in thestated range. Where the stated range includes one or both of the limits,ranges excluding either or both of those included limits are alsoincluded.

As used herein and in the appended claims, the singular forms “a”, “an”,and “the” include plural referents unless the context clearly dictatesotherwise. Thus, for example, reference to “a process” includes aplurality of such processes and reference to “the device” includesreference to one or more devices and equivalents thereof known to thoseskilled in the art, and so forth.

Also, the words “comprise,” “comprising,” “include,” “including,” and“includes” when used in this specification and in the following claimsare intended to specify the presence of stated features, integers,components, or steps, but they do not preclude the presence or additionof one or more other features, integers, components, steps, acts, orgroups.

What is claimed is:
 1. A catheter for delivering and aligning a heartimplant about a wall of a heart, the catheter comprising: an elongatecatheter body having a lumen disposed there through; a handle mechanismdisposed at a proximal end of the elongate catheter body; a cavitywithin a distal end of the elongate catheter body that is configured todeliver a heart implant, the cavity being configured to receive theheart implant such that at least a portion of the heart implant isexposed to an interior region of the heart; and a cable positionedwithin the lumen of the elongate catheter body, the cable beingreleasably coupled with the heart implant positioned within the cavityand being operationally coupled with the handle mechanism so that afirst operation of the handle mechanism causes the cable to flex outwardfrom the cavity and thereby cause at least part of the heart implant tomove outward from the cavity.
 2. The catheter of claim 1, wherein asecond operation of the handle mechanism causes the cable to retractwithin the lumen of the elongate catheter body thereby enabling theheart implant to be repositioned within the cavity.
 3. The catheter ofclaim 2, wherein a third operation of the handle mechanism causes thecable to retract within the lumen of the elongate catheter body therebyenabling the heart implant to be released from the cavity.
 4. Thecatheter of claim 1, wherein the heart implant is pivotably coupled witha tension member.
 5. The catheter of claim 1, wherein a distal tip ofthe elongate catheter body is plugged or capped so that the lumen doesnot extend through the distal tip, and wherein a distal end of the cablecontacts the distal tip of the elongate catheter body such that distalsliding of the cable within the lumen causes the cable to flex outwardfrom the cavity.
 6. The catheter of claim 1, wherein the cavity isformed in the distal end of the elongate catheter body by removing morewith more than ½ of the material of the elongate catheter body such thata strip of material connects a proximal portion and distal portion ofthe elongate catheter body on opposite sides of the cavity.
 7. Thecatheter of claim 1, wherein the cable is slidably disposed through alumen of the heart implant.
 8. The catheter of claim 1, wherein thedistal end flexes or bends in response to the first operation of thehandle mechanism, and wherein the heart implant pivots outward from thecavity in response to the first operation of the handle mechanism.
 9. Aheart implant alignment and delivery device comprising: an elongatebody; an opening in the elongate body that is disposed near a distal endof the elongate body, the opening being configured such that a heartimplant is positionable within the opening so that the heart implant isexposed to a surrounding environment and so that the heart implant issubstantially aligned with the distal end of the elongate body; and animplant reposition member that is releasably coupleable with the heartimplant and that is operationally coupled with the elongate body suchthat a first operation of the implant reposition member causes the heartimplant to be retractably deployed from the opening of the elongatebody.
 10. The device of claim 9, further comprising a handle mechanismthat is disposed at a proximal end of the elongate body, the handlemechanism being operably coupled with the implant reposition member toeffect the first operation of the implant reposition member.
 11. Thedevice of claim 9, wherein retractably deploying the heart implantcomprises pivoting the heart implant out of the opening.
 12. The deviceof claim 9, wherein the implant reposition member is further configuredsuch that a second operation of the implant reposition member causes theheart implant to be retracted into the opening with the heart implantsubstantially aligned with the distal end of the elongate body.
 13. Thedevice of claim 12, wherein the implant reposition member is furtherconfigured such that a third operation of the implant reposition membercauses the heart implant to be permanently deployed from the opening ofthe elongate body.
 14. The device of claim 12, wherein the implantreposition member is a cable that is slidably disposed within a lumen ofthe elongate body, and wherein the elongate body is configured such thatthe distal sliding of the cable within the lumen of the elongate bodycauses a portion of the cable to protrude outwardly from the opening.15. A method of deploying a heart implant from a catheter that includesan elongate body having a lumen and a cavity, a cable disposed withinthe lumen, a handle mechanism disposed at a proximal end of the elongatebody, and the heart implant positioned within the cavity, the methodcomprising: positioning a distal end of the elongate body within achamber of a heart so that the cavity and heart implant are adjacent awall of the heart; and performing a first operation via the handlemechanism to cause the cable to flex outward from the cavity of theelongate body and thereby cause the heart implant to pivot out of thecavity of the elongate body and into contact with the wall; wherein theheart implant is retractable within the cavity to enable repositioningof the elongate body within the heart and thereby ensure a properalignment of the heart implant relative to the wall of the heart. 16.The method of claim 15, further comprising performing a second operationvia the handle mechanism to cause the cable to retract within the lumenof the elongate body and thereby cause the heart implant to retract intothe cavity, wherein the cavity and heart implant are repositionablewithin the cavity of the heart after retraction of the cable and heartimplant.
 17. The method of claim 16, further comprising repositioningthe cavity and heart implant within the chamber of the heart so that theheart implant is repositioned relative to the wall and performing anadditional first operation of the handle mechanism to cause the cable toflex outward from the cavity and thereby cause the heart implant topivot out of the cavity and into contact with the wall.
 18. The methodof claim 15, further comprising performing a third operation with thehandle mechanism to permanently deploy the heart implant from the cavityof the elongate body.
 19. The method of claim 15, wherein the heartimplant is pivotably coupled with a tension member that extend distallyfrom heart implant and through the wall of the heart.
 20. The method ofclaim 15, wherein the cable is slidably disposed through a lumen of theheart implant.